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Sponsored by: |
Biomet Orthopedics, LLC |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00585988 |
The primary purpose of this study is to compare early functional outcomes in patients undergoing hip resurfacing and total hip arthroplasty with the M2a-Magnum™ using more objective measures of function.
Condition | Intervention |
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Osteoarthritis Rheumatoid Arthritis Arthritis Traumatic Arthritis |
Device: Hip Resurfacing System Device: M2a-Magnum™ Large Metal Articulation |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | Functional Recovery Following Hip Resurfacing or Total Hip Arthroplasty in Patients Matched By Age, Gender, and Activity Level |
Estimated Enrollment: | 150 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 |
Device: Hip Resurfacing System
This arm will utilize a hip resurfacing system.
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2 |
Device: M2a-Magnum™ Large Metal Articulation
This arm will utilize the M2a-Magnum™ implant system.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Biomet Orthopedics, Inc. ( Kenneth J. Beres, MD, Director of Clinical Research ) |
Study ID Numbers: | 292-U-010 |
Study First Received: | December 21, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00585988 |
Health Authority: | United States: Institutional Review Board |
Autoimmune Diseases Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immune System Diseases |